Neostigmine For Snoring During DISE

Snoring Clinical Trial

Official title:

Local Neostigmine for Treatment of Snoring During Drug-Induced Sleep Endoscopy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03316963
• Other study ID #: IRB00096770
• Status: Terminated
• Phase: Early Phase 1
• Start date: November 14, 2017
• Est. completion date: March 19, 2019

Study information

• Verified date: June 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study team is seeking a novel treatment for snoring involving local application of a nerve stimulant medication, neostigmine. In this study, neostigmine will be injected into 5 sites of the soft palate during a standard procedure, drug-induced sleep endoscopy, to evaluate the effect on snoring.

Description:

Snoring is a major problem, affecting 40 million Americans. The disease affects patient and partner sleep quality as well as daytime function. Snoring treatment is limited by device compliance (mouth appliance, positive airway pressure) and insurance does not regularly pay for these devices. Surgical treatment for snoring has mixed results. As a result, there is an important need to develop new treatments for snoring.

The study team is seeking a novel treatment for snoring involving local application of a nerve stimulant medication, neostigmine. In this study, neostigmine will be injected into 5 sites of the soft palate during a standard procedure, drug-induced sleep endoscopy, to evaluate the effect on snoring. If successful, development of a topical (non-injectable) version of this drug will be considered, so that the patient can apply him/herself before bedtime.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 19, 2019
• Est. primary completion date: March 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Snoring or mild obstructive sleep apnea

• English-speaking

• Greater than 18 years old

• Able to give informed consent

Exclusion Criteria:

• On active anti-coagulation medication

• Pregnant women

• Hypersensitivity to neostigmine

• Peritonitis or mechanical obstruction of the intestinal or urinary tract

• Coronary artery disease

• Cardiac arrhythmia

• Recent acute coronary syndrome

• Myasthenia gravis

Related Conditions & MeSH terms

• Snoring

Intervention

Drug:
• Neostigmine Methylsulfate
After the patient demonstrates snoring and obstruction collapse, the patient will receive the study medication (neostigmine methylsulfate 1mg/mL) into the soft palate with co-administration of intravenous glycopyrrolate 0.2mg. At each of 5 injection sites on the soft palate , 0.5 mL (0.5mg) of neostigmine methylsulfate will be administered, yielding a total of 2.5mg (2.5mL) of neostigmine methylsulfate. The medication will be administered using five 1 mL syringes filled with 0.5 mL neostigmine each. Following administration of neostigmine, the patient will be observed for an additional 4 minutes to examine both vibration and sound emanating from the soft palate. The anticipated time under sedation will be 14 minutes.

Locations

Country	Name	City	State
United States	Raj C. Dedhia	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in decibel sound after injection of neostigmine	The data will come from the drug-induced sleep endoscopy (DISE) audio and video recordings. Prior to the neostigmine injection, a snoring microphone will be placed over the right clavicle. Following administration of neostigmine, the patient will be observed for an additional 4 minutes to examine sound emanating from the soft palate. Total run time, instantaneous decibel levels, LAeq (average decibel level over time), and the maximum decibel level will be recorded.	The DISE will occur up to 30 days after the pre-op visit and study enrollment
Primary	Change in soft palate motion after injection of neostigmine	The data will come from the drug-induced sleep endoscopy (DISE) audio and video recordings. Following administration of neostigmine, the patient will be observed for an additional 4 minutes to examine vibration emanating from the soft palate.	The DISE will occur up to 30 days after the pre-op visit and study enrollment